MAUDE Adverse Event Report: COOPERSURGICAL INC. EXTRCTR CUP SUPER MUSHROOM

Model Number	10008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
Details reported on incoming (b)(4) are as follows: "when pulling, doctor had a feeling that cup is about to break (sound, feeling in hand when pulling).They changed the cup to the same kind of cup.That cup was fine.Nevertheless delivery ended up to emergency c-section.Changing the cup took time and that way effected to decision." "patient (mother) suffered 2000 ml blood loss and had blood transfusion (2 units) one day after delivery.She has recovered and been discharged from hospital.Midwife didn't tell me baby's status.".
Additional Manufacturer Narrative
Investigation.X-review dhr.X-inspect returned samples.Analysis and findings.(b)(4).Distribution history: this complaint unit was manufactured at csi on (b)(6)2021 under wo #(b)(4).And shipped on (b)(6) 2022.Manufacturing record review: dhr-303616 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-910000-310035- lot number lm236215 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint product was returned on (b)(6)2023 on rma number 343454.The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed no physical damage.There were no cracks or splits in the cup or stem.Functional evaluation: complaint product was functionally evaluated and found to function properly.Root cause: root cause not applicable as the complaint condition was not confirmed.Per the notes of the complaint the doctor is used to using part number 10007lp, therefore it is possible that the customers inexperience with part number 10008 might have contributed to the complaint.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*was the complaint confirmed? no.*preventative action activity.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
Details reported on incoming (b)(4).Are as follows: "when pulling, doctor had a feeling that cup is about to break (sound, feeling in hand when pulling).They changed the cup to the same kind of cup.That cup was fine.Nevertheless delivery ended up to emergency c-section.Changing the cup took time and that way effected to decision." "patient (mother) suffered 2000 ml blood loss and had blood transfusion (2 units) one day after delivery.She has recovered and been discharged from hospital.Midwife didn't tell me baby's status.".

• Brand Name: EXTRCTR CUP SUPER MUSHROOM
• Common Device Name: EXTRCTR CUP SUPER MUSHROOM
• Manufacturer (Section D): COOPERSURGICAL INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16600576
• Report Number: 1216677-2023-00057
• Device Sequence Number: 6165254
• Product Code: HDB
• UDI-Device Identifier: 00888937003055
• UDI-Public: 888937003055
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K890307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10008
• Device Catalogue Number: 10008
• Device Lot Number: 303616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown